Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
febuxostat
Mylan Pharmaceuticals Limited
M04AA03
febuxostat
Antigout preparations
Hyperuricemia; Arthritis, Gouty; Gout
Febuxostat Mylan is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).Febuxostat Mylan is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).Febuxostat Mylan is indicated in adults.
Revision: 11
Authorised
2017-06-15
64 B. PACKAGE LEAFLET 65 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FEBUXOSTAT VIATRIS 80 MG FILM-COATED TABLETS FEBUXOSTAT VIATRIS 120 MG FILM-COATED TABLETS febuxostat READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Febuxostat Viatris is and what it is used for 2. What you need to know before you take Febuxostat Viatris 3. How to take Febuxostat Viatris 4. Possible side effects 5. How to store Febuxostat Viatris 6. Contents of the pack and other information 1. WHAT FEBUXOSTAT VIATRIS IS AND WHAT IT IS USED FOR Febuxostat Viatris tablets contain the active substance febuxostat and are used to treat gout, which is associated with an excess of a chemical called uric acid (urate) in the body. In some people, the amount of uric acid builds up in the blood and may become too high to remain soluble. When this happens, urate crystals may form in and around the joints and kidneys. These crystals can cause sudden, severe pain, redness, warmth and swelling in a joint (known as a gout attack). Left untreated, larger deposits called tophi may form in and around joints. These tophi may cause joint and bone damage. Febuxostat Viatris works by reducing uric acid levels. Keeping uric acid levels low by taking Febuxostat Viatris once every day stops crystals building up, and over time it reduces symptoms. Keeping uric acid levels sufficiently low for a long enough period can also shrink tophi. Febuxostat Viatris 120 mg tablets are also used to treat and prevent high blood levels of uric acid that may occur whe Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Febuxostat Viatris 80 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg of febuxostat. Excipient with known effect Each tablet contains 236.0 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). A yellow, capsule shaped, biconvex tablet approximately 16 x 7 mm, debossed with M on one side of the tablet and FX3 on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Viatris is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended oral dose of Febuxostat Viatris is 80 mg once daily without regard to food. If serum uric acid is > 6 mg/dL (357 µmol/L) after 2-4 weeks, Febuxostat Viatris 120 mg once daily may be considered. Febuxostat Viatris works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L). Gout flare prophylaxis of at least 6 months is recommended (see section 4.4). _Elderly_ No dose adjustment is required in the elderly (see section 5.2). _Renal impairment _ The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance <30 mL/min, see section 5.2). No dose adjustment is necessary in patients with mild or moderate renal impairment. 3 _Hepatic impairment_ The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C). The recommended dose in patients with mild hepatic impairment is 80 mg. Limited information is available in patients with moderate hepatic impairment. _Paediatric population_ The safety and the efficacy of febuxostat in children aged below the age of 18 year Прочетете целия документ